Assay Development
Stephen Lundy of Venaxis Inc. (formerly AspenBio Pharma) Any parent who has rushed to Urgent Care with a toddler shrieking in abdominal pain will appreciate the big opportunity Stephen Lundy saw when he became head of Venaxis Inc. (formerly AspenBio Pharma). A 25-year veteran of the IVD industry, Lundy says the market potential of the appendicitis blood test that the company was developing lured him from his CEO post at MicroPhage to Venaxis’s Colorado headquarters. When Lundy...
Table 1. Capillary flow times for Hi-Flow Plus membranes. *The range is for all measured values on a roll and represents ±3∂. The acceptable range for the mean is ±10% of the target.   Selecting, evaluating, and sourcing critical raw materials is a strategic step in the development and production of diagnostic kits. This is also a strategic task for company management, because an IVD company always must optimize its return...
Figure 1. Loading results for analysis. Aptamers were first discovered in 1989 by Craig Tuerk and Larry Gold. The classic definition of an aptamer is a single-stranded oligonucleotide (RNA or DNA) that has the capacity to mimic an antibody in terms of binding to specific analytes. Many have predicted that this discovery represented a technology with the potential to rival the antibody revolution in molecular diagnostic testing. Years have passed, and while many aptamers have been...
When developing an IVD device, typically the first thing that comes to mind is the assay: what is the sample being tested for and how is the target detected? This is the central thinking of most companies, whether they are setting out to extend a product’s lifespan or to bring a disruptive new technology to market. However, while the assay is core, focusing exclusively on this can significantly minimize the potential market scope and lead to commercial failure. In this article we will...
  Shopping for parts, components, services, and new technologies at the Clinical Lab Expo next week? You're in luck. Here's just a tiny sampling of what will be on display there. Isolation Miniature Valves Solenoid-operated valves use a flexible diaphragm to isolate the solenoid actuation mechanism from the fluid path. When the valve is energized, the solenoid retracts an armature that is attached to a flexible diaphragm. In a normally closed valve, this raises the diaphragm, allowing...
Procalcitonin (PCT) is the precursor of calcitonin (CT), a hormone that originates in the thyroid gland and reduces blood calcium. The importance of CT in humans is still not well established, compared with its importance in various animal species.1 This is interesting when juxtaposed with the role its precursor PCT plays in diagnosing infections in hospitals all over the world (see Figure 1). PCT has been a valuable marker for bacterial sepsis for nearly two decades, ever since it was...
The Clinical Lab Expo will feature new science and technology in every area of clinical diagnostics, automation, information systems, point of care, OEM, and biotech. Roughly 750 organizations will occupy about 2000 booths. According to Clinical Lab Expo's Website, "You will see more products in every clinical lab discipline than at any other show." Find What You Need The Clinical Lab Expo will have special sections for special products. Visit the special sections for point-of-...
Molecular diagnostics, POC diagnostics, and hematology are expected to see continued growth. The current IVD market includes immunochemistry, molecular diagnostics, blood donor screening, hematology, hemostasis, and point-of-care testing. As the IVD market evolves to become more efficient and less costly, a shift from manual testing to automated methods is essential. Furthermore, as patient care shifts from the hospital to the alternate care setting, IVD is likely to follow. Overall...
Figure 1. Rising procalcitonin (PCT) values with severity of sepsis.6 The incidence of sepsis is rapidly increasing, causing significant challenges for hospital critical care physicians who typically treat the condition. A common and frequently fatal condition, sepsis results from an inflammatory response to an infection. Infants, children, the elderly, and people with weak immune systems are particularly susceptible to sepsis. The infectious agent travels from the initial site...
Hemoglobin A1c (HbA1c) is uniquely suited for diagnosing diabetes and monitoring its treatment with a specific number of tests per year (typically on a quarterly basis). Recent initiatives by the United Nations, the World Health Organization, and the International Diabetes Federation (IDF) have addressed the worldwide diabetes epidemic and the need for better diagnosis and treatment. At the 2010 National Glycohemoglobin Standardization Program (NGSP) Manufacturers’ Forum, the president of...